Tongue HabitsNCT05792553
Effects of Tongue Tamers as an Early Treatment of Anterior Open Bite
A study testing bonded tongue tamers, customized bonded spurs and conventional fixed palatal spurs in people with Tongue Habits and Open Bite, run by Tanta University at 1 site in Egypt.
Trial summary
Anterior open bite (AOB) is a malocclusion that causes aesthetic, speech, feeding, and psychological concerns, emphasizing the significance of beginning treatment as soon as possible to correct the disorder. Read more about this study
- Who is it for?
- Ages 7 to 9 years
- Conditions the study is for
- Tongue Habits, Open Bite
- What is being tested?
- bonded tongue tamers, customized bonded spurs and conventional fixed palatal spurs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 25 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- male or female patients in early mixed dentition period with age range 7-9 years
- dental anterior open bite equal to or greater than 1 mm,
- class I malocclusion
- clinical signs of anterior tongue thrusting.
Who cannot join
- Patients with skeletal open bite
- posterior crossbite
- tooth agenesis or loss of permanent teeth
- crowding,
- systemic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Tongue Tamers and Customized Bonded Spurs as an Early Treatment of Anterior Open Bite: A Randomized Clinical Study
Anterior open bite (AOB) is a malocclusion that causes aesthetic, speech, feeding, and psychological concerns, emphasizing the significance of beginning treatment as soon as possible to correct the disorder. The main etiological determinants of AOB include finger-sucking, pacifiers, and oral habits; hence, it is vital to use interceptive treatments focused on correcting and increasing bite stability during childhood to avoid the need for advanced therapy
- Conditions
- Tongue Habits, Open Bite
- Being tested
- bonded tongue tamers, customized bonded spurs, conventional fixed palatal spurs
- Keywords
- open bite, tongue thrust, habit breaking appliance
- Medical subject headings
- Tongue Habits, Open Bite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bonded tongue tamersDevice
Enamel surface will be treated initially with 37% phosphoric acid for 30 seconds then tongue tamers will be bonded to the palatal/lingual surface of upper and lower central incisors
customized bonded spursDevice
Composite restoration will be used to fabricate the customized bonded spurs with sharp ends and 3 mm in length.
conventional fixed palatal spursDevice
conventional fixed palatal spurs will be fabricated by taking impression after band selection, then the spurs appliance will be fabricated from 0.9 mm stainless steel wire and soldered to the bands bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| group I: bonded tongue tamers | Experimental | 25 cases with anterior open bite will be treated using bonded tongue tamers Receives: Device: bonded tongue tamers |
| group II: customized bonded spurs | Experimental | 25 cases with anterior open bite will be treated using customized bonded spurs Receives: Device: customized bonded spurs |
| group III: conventional fixed palatal spurs | Active comparator | 25 cases with anterior open bite will be treated using conventional fixed palatal spurs Receives: Device: conventional fixed palatal spurs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the anterior open bite
Measuring method: Digital caliper Measuring unit: Binary (+/-)
Measured: 3 months
Secondary outcomes (1)
cephalometric variables
cephalometric variables including SNA°, SNB°, ANB°, FMA°, U1/FHP°, L1/GoGn°, and overjet will be analyzed pre- and post- treatment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start1 Mar 2023
- Primary completion1 Jun 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tongue HabitsStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safa Basiouny Alawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792553
- Sponsor's protocol ID
- #R-ORTH-2-23-5
- Status last verified
- Nov 2023
- First submitted
- 19 Mar 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alawy SB, El-Desouky SS, Kabbash IA, Hadwa SM. Effects of tongue tamers and customized bonded spurs as an early treatment of anterior open bite: a randomized clinical study. BMC Oral Health. 2025 Jan 16;25(1):76. doi: 10.1186/s12903-024-05389-x.
PubMed 39819458
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tongue Tamers and Customized Bonded Spurs as an Early Treatment of Anterior Open Bite: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT05792553
- Acronym / sponsor ID
- #R-ORTH-2-23-5
- Conditions
- Tongue Habits, Open Bite
- Keywords
- open bite, tongue thrust, habit breaking appliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anterior open bite (AOB) is a malocclusion that causes aesthetic, speech, feeding, and psychological concerns, emphasizing the significance of beginning treatment as soon as possible to correct the disorder. The main etiological determinants of AOB include finger-sucking, pacifiers, and oral habits; hence, it is vital to use interceptive treatments focused on correcting and increasing bite stability during childhood to avoid the need for advanced therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group I: bonded tongue tamers | Experimental | Device: bonded tongue tamers25 cases with anterior open bite will be treated using bonded tongue tamers |
| group II: customized bonded spurs | Experimental | Device: customized bonded spurs25 cases with anterior open bite will be treated using customized bonded spurs |
| group III: conventional fixed palatal spurs | Active comparator | Device: conventional fixed palatal spurs25 cases with anterior open bite will be treated using conventional fixed palatal spurs |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- male or female patients in early mixed dentition period with age range 7-9 years
- dental anterior open bite equal to or greater than 1 mm,
- class I malocclusion
- clinical signs of anterior tongue thrusting.
Key exclusion criteria (5 listed)
- Patients with skeletal open bite
- posterior crossbite
- tooth agenesis or loss of permanent teeth
- crowding,
- systemic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bonded tongue tamersEnamel surface will be treated initially with 37% phosphoric acid for 30 seconds then tongue tamers will be bonded to the palatal/lingual surface of upper and lower central incisors | Device | group I: bonded tongue tamers |
| customized bonded spursComposite restoration will be used to fabricate the customized bonded spurs with sharp ends and 3 mm in length. | Device | group II: customized bonded spurs |
| conventional fixed palatal spursconventional fixed palatal spurs will be fabricated by taking impression after band selection, then the spurs appliance will be fabricated from 0.9 mm stainless steel wire and soldered to the bands bilaterally. | Device | group III: conventional fixed palatal spurs |
Primary outcome
Change of the anterior open bite
Time frame: 3 months
Measuring method: Digital caliper Measuring unit: Binary (+/-)
1 secondary outcome
cephalometric variables
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Derived from this study: PubMed 39819458Alawy SB, El-Desouky SS, Kabbash IA, Hadwa SM. Effects of tongue tamers and customized bonded spurs as an early treatment of anterior open bite: a randomized clinical study. BMC Oral Health. 2025 Jan 16;25(1):76. doi: 10.1186/s12903-024-05389-x.
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Not yet recruitingObservational study
Tongue and Occlusal Pressure Performance and Dietary Habits in Maxillectomy Patients With Obturator Prostheses
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bonded tongue tamers, customized bonded spurs and conventional fixed palatal spurs in people with Tongue Habits and Open Bite, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the anterior open bite (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05792553, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.